Clinical Trial: Clinical Performance of Biofinity Toric Versus Air Optix for Astigmatism

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Single-Center Study Comparing the Clinical Performance of Biofinity Toric Versus Air Optix for Astigmatism Over 1 Month of Daily Wear.

Brief Summary: The aim of this study is to compare the clinical performance of the Biofinity Toric (comfilcon A) contact lens, versus Air Optix for Astigmatism (lotrafilcon B) over 1 month of daily wear.

Detailed Summary: Single masked, open label, randomized, bilateral, crossover study design comparing comfilcon A against lotrafilcon B lenses over 1 month of daily wear for each study lens. Each subject will be randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating the schedule for the second pair without a washout period.
Sponsor: Coopervision, Inc.

Current Primary Outcome:

  • Daily and Comfortable Wearing Time [ Time Frame: Baseline ]
    Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses. (The hours of average comfortable wearing time and average daily wearing time.)
  • Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction [ Time Frame: Baseline ]
    Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at baseline for all habitual lenses. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)
  • Vision Quality Insertion, During Day, End Day [ Time Frame: Baseline ]
    Participant rating of vision quality on insertion, during the day, end of day. Collected at baseline for all habitual lenses. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)
  • Vision Stability Insertion, During Day, End Day [ Time Frame: Baseline ]
    Participant rating of vision stability on insertion, during the day, end of day. Collected at baseline for all habitual lenses. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)
  • Overall Sensation of Moistness [ Time Frame: Baseline ]
    Participant rating for overall sensation of moistness. Collected at baseline for all habitual lenses. (5-point Likert Scale; Excellent, Good, Average, Below Av

    Original Primary Outcome: Subjective Assessment: Change in Comfort, dryness, handling and lens fit. [ Time Frame: Change from baseline over 8-weeks ]

    Subjective Assessment: Assessed by subject on a Visual Analog Scale from 0 -10.

    • Comfort: (10=can't feel)
    • Dryness: (10=no dryness)
    • Handling: (10=very easy)
    • Fit: (10=very stable)


    Current Secondary Outcome:

    • Limbal Hyperaemia [ Time Frame: Baseline ]
      Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
    • Limbal Hyperaemia [ Time Frame: 2 weeks ]
      Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
    • Limbal Hyperaemia [ Time Frame: 4 weeks ]
      Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
    • Bulbar Hyperaemia [ Time Frame: Baseline ]
      Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
    • Bulbar Hyperaemia [ Time Frame: 2 weeks ]
      Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
    • Bulbar Hyperaemia [ Time Frame: 4 weeks ]
      Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
    • Lower Palpebral Hyperaemia [ Time Frame: Baseline ]
      Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
    • Lower Palpebral Hyperaemia [ Time Frame: 2 weeks ]
      Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
    • Lower Palpebral Hyperaemia [ Time Frame: 4 weeks ]
      Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
    • Corneal Stromal Haze [ Time Frame: Baseline ]
      Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
    • Corneal Stromal Haze [ Time Frame: 2 weeks ]
      Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
    • Corneal Stromal Haze [ Time Frame: 4 weeks ]
      Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
    • Corneal Neovascularization [ Time Frame: Baseline ]
      Investigators' objective assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
    • Corneal Neovascularization [ Time Frame: 2 weeks ]
      Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
    • Corneal Neovascularization [ Time Frame: 4 weeks ]
      Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
    • Corneal Infiltrates [ Time Frame: Baseline ]
      Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)
    • Corneal Infiltrates [ Time Frame: 2 weeks ]

      Original Secondary Outcome:

      • Subjective Assessment: Change in Vision [ Time Frame: Change from baseline over 8-weeks ]
        Subjective Assessment: Assessed by subject on a Visual Analog Scale fro 0-10. Vision (10=very satisfied)
      • Objective Practitioner Measurements: Ocular response [ Time Frame: Visits: V1 (baseline), V2 (2 weeks), V3 (4 weeks) V4 (6-weeks) V5 (8-weeks) ]

        Objective Practitioner Measurements (Biomicroscopy): Ocular response assessed using slit lamp with white light, low-medium magnification.

        (Brien Holden Vision Institute grading scales for reference, ½ grades recorded.)

        • 0 NONE
        • 1 VERY SLIGHT
        • 2 SLIGHT
        • 3 MODERATE
        • 4 SEVERE


      Information By: Coopervision, Inc.

      Dates:
      Date Received: October 11, 2013
      Date Started: September 2013
      Date Completion:
      Last Updated: November 6, 2014
      Last Verified: November 2014